Standard Operating Procedures

Standard operating procedure (SOP) is defined as the established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations. It is a document consisting of step by step information on how to execute a task. It is a set of written instructions that document a routine or repetitive activity which is followed by an organization. In a manufacturing organization, an SOP is the step by step production line procedures used to run a process for producing a product as well to train employees.

The existence of documented procedures enhances the value of an organization. It shows that the organization is a professional organization which is process driven, rather than top management driven. Process driven organizations create a higher level of confidence amongst the customers.

The development and use of SOPs provides individuals with the information to carry out the operations correctly and always in the same manner. By helping to perform a job properly, SOP facilitates in maintaining the quality control and quality assurance processes besides consistency in the quality and integrity of a product or end result. SOPs are intended to be specific to the organization or facility whose activities are described. They describe the activities necessary to complete tasks in accordance with industry regulations, process discipline, local laws or even just organizational own internal standards.

The details in an SOP standardize the process and provide step-by-step how-to instructions that enable anyone within the organization to perform the task in a consistent manner. The SOP document serves as an instructional resource that allows employees to act without asking for directions, reassurance, or guidance. The step-by-step written procedure can also help to hold the employees accountable because employee expectations are documented and their actions can be measured against the SOP.

If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs needed to be reviewed and re-enforced by management, preferably the direct supervisor. Current copies of the SOPs also need to be readily accessible for reference in the work areas of those individuals actually performing the activity, either in hard copy or electronic format, otherwise SOPs serve little purpose.

SOPs, in fact, define expected practices and play an important role in the organization. They are policies, procedures and standards that employees of the organization need in the operations, marketing, administration, and other disciplines to ensure success. The benefits which SOPs can bring to the organization are as follows.

Ensures the processes of the organizations takes place with minimum of variability

Reduces system variations and due to it improves efficiencies in operations and therefore profitability

Provides consistency and reliability in production and service

Results into fewer errors during the operational activities in all the areas

Helps to resolve conflicts between employees

Ensures compliance of the regulatory provisions

Creates a healthy and safe working environment

Helps in trouble shooting problems during operation

Helps to deal with emergency situation

Protects management in the areas of potential liability

Acts as a roadmap for how to resolve issues by allowing needed focus on solving the problem

Helps creating systematic historical records in the organization

Well written SOPs help in employees training and retraining.

SOPs contribute maximum towards continuous improvement efforts

Since SOPs are written by persons with practical experience in the process, they are not the theoretical documents. They have practicalities of the work processes built into them.

Creation of SOP

The process of writing a new SOP or modifying and updating an existing SOP is quite laborious but once completed brings a large number 0f benefits to the organization. Before creating different SOPs in the organization, a master SOP is to be written which should include among various other things the numbering system for SOPs, norms for the persons authorized to write and to approve SOPs, methodology for SOP creation, the approval mechanism for SOPs, change control mechanism for SOPs (including frequency of revisions and reviews etc.), standard terminology (such as acronyms, symbols, abbreviations, paragraphing, headings and sub headings etc.) to be used, methodology for record maintenance and a check list for the writer of the SOP.

Various steps in the creation of an SOP are described below.

Formatting – There is no standard format which is used universally for an SOP. An organization can choose a particular format to suit its requirements. The chosen format becomes the standard format for the organization which needs to be followed for all the SOPs in the organization.

User of SOPs – SOPs are to be written considering the knowledge base of the employees for whom they are meant. The language and terminology used in SOPs should be familiar to the employees using it.

Author of SOPs – SOPs are to be written by persons who have thorough knowledge of the process and who are well experienced. A poorly or inaccurately written SOP not only reduces productivity and leads to operational failures, but it can also be unsafe and have adverse impacts on the results expected from the team as well as on the working environment.

Length of SOPs – An SOP should not be a very lengthy document, though it must include all the steps needed for the procedure. Elaborations if needed for any step are to be covered under a supplementary document usually known as work instructions. Suitable reference of the work instructions is to be made at the relevant step in the SOP.

SOP is to carry the subject, identity of the author, approving authority, date of initial issue, number of revisions and the date of latest revision

SOP is to describe the purpose of the process and its limitations.

SOP should also include dangers of the process and precautions required to be taken.

SOP should mention the applicable standards, regulatory requirements, roles and responsibilities, as well as inputs and outputs of the process.

Besides work instructions, SOP should make appropriate reference to the other documents (such as operation and maintenance manuals, vision and mission statements, apex manual, and safety manual etc.) which have been used for the preparation of the SOP.

SOP should be clear and concise but with enough details so that users with a basic understanding but limited experience can follow the procedure. SOPs should not use long descriptive sentences. The sentences should be short, clear and to the point.

SOPs should standardize the formats needed for record keeping.

While writing a procedure, the following are to be kept in mind.

SOP must ensure compliance of internal and external standards

SOP must not violate the vision, mission and objectives of the organization

SOP should comply the requirements of the operation manuals of the supplier

Ideally SOP should be made in a manner that it can be used as a training document.

The originals of SOPs should be kept at a secure place while working copies should be authenticated with stamps and/or signatures of the authorized persons. These authenticated copies are to be available at the places where the work is carried out.

For SOPs to be effective, the employees who have to implement the SOPs are to read and understand the process described in the SOPs.

SOPs are not the documents of permanent nature. SOP needs modification as and when there is change in the environment of the process. In such a case the SOP is to be revised. These revisions are carried out as per the change control mechanism.

Fig 1 shows all the steps from planning/designing to updating/revising of the SOP.